BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 LEAD SET SNAP AAMI, ICU

    MDR report key: 3844735 · Received March 12, 2014

    Report

    Report Number
    9610816-2014-00064
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Report Date
    February 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSA
    PMA / PMN Number
    K020531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FAILURE OF AN M1602A ECG LEAD SET. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149705 5 LEAD SET SNAP AAMI, ICU DSA PHILIPS MEDICAL SYSTEMS M1644A 2011-02

    Patients

    Seq Age Sex Outcome Treatment
    1